CompletedPhase 2

Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children

France49 participantsStarted 2005-12

Plain-language summary

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

Who can participate

Age range1 Year – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children and adolescents aged 1 to 17 years at diagnostic * Documented Ph+ ALL * Eligibility for the current local prospective therapeutic study of childhood ALL * Informed consent given by the parents or by legal guardian Exclusion Criteria: * Abnormal hepatic functions * Abnormal renal functions * Active systemic bacterial, fungal or viral infection

What they're measuring

Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies.

Timeframe: 2 years

Trial details

NCT IDNCT00287105

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03-30

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